Safety Trial of Patient Specific Guides for Lumbar Fusion
NCT ID: NCT04751981
Last Updated: 2021-02-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
80 participants
INTERVENTIONAL
2021-02-28
2023-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
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Patient Specific Guide
Patients randomized into this group will have pedicle screws placed with the aid of patient specific surgical guides.
Patient Specific Guide
For lumbar fusion pedicle screws will be placed with the aid of patient specific guides.
Navigation
Patients randomized into this group will have pedicle screws placed with conventional navigation.
Navigation
Conventional navigation will be used to place pedicle screws.
Interventions
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Patient Specific Guide
For lumbar fusion pedicle screws will be placed with the aid of patient specific guides.
Navigation
Conventional navigation will be used to place pedicle screws.
Eligibility Criteria
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Inclusion Criteria
* Indication for lumbar spine surgery requiring pedicle screw instrumentation through a posterior approach with fusion.
* Recently has or requires a CT-scan of the spine
* No previous spine surgery on the level being used for patient specific guides
* Sufficient understanding of the English language or interpretation assistance available.
Exclusion Criteria
* History of psychiatric disorders
* Previous spine surgery adjacent or at the level of the surgery
* Unable to read or comprehend the consent form/letter of information
18 Years
ALL
No
Sponsors
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London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
OTHER
Responsible Party
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Other Identifiers
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10079
Identifier Type: -
Identifier Source: org_study_id
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